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Search / Trial NCT03705312

MitraClip for the Treatment of Moderate Functional Mitral Regurgitation: EVOLVE-MR

Launched by MONTREAL HEART INSTITUTE · Oct 11, 2018

Trial Information

Current as of June 20, 2025

Unknown status

Keywords

Mitral Regurgitation Transcatheter Mitral Valve Repair

ClinConnect Summary

Moderate mitral regurgitation in patients with LV dysfunction is associated with increased risk of death and hospitalizations for heart failure (HF) and leads to progressive remodelling of an already damaged left ventricle. Medical therapies and cardiac resynchronization therapy (CRT) have demonstrated favourable effects on LV remodelling in heart failure patients.

Given the benefits and safety of transcatheter mitral valve repair with the MitraClip device in severe MR, it is conceivable that this technology could also be safely used in those with moderate MR to reduce mitral regurgitation...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Moderate functional mitral regurgitation (2+, 2-3+)
  • Left ventricular ejection fraction \>20%
  • LVEDV 75-110 ml/m2
  • Symptomatic heart failure (NYHA Class II-IV)
  • Exclusion Criteria:
  • Left ventricular ejection fraction \< 20%
  • Severe functional mitral regurgitation
  • Recent coronary artery bypass graft surgery (CABG)
  • Untreated significant coronary artery disease
  • Mitral valve area \< 4.0cm2
  • Severe pulmonary hypertension

About Montreal Heart Institute

The Montreal Heart Institute (MHI) is a leading academic research center dedicated to advancing the field of cardiology through innovative clinical trials and groundbreaking medical research. Renowned for its commitment to improving patient care, MHI integrates clinical practice with cutting-edge research, fostering collaboration among healthcare professionals, scientists, and industry partners. The institute focuses on a wide range of cardiovascular conditions, aiming to develop and evaluate new therapies and interventions that enhance outcomes for patients with heart disease. With a strong emphasis on ethical standards and patient safety, the Montreal Heart Institute is at the forefront of cardiovascular research, contributing significantly to the global advancement of heart health.

Locations

Montréal, Quebec, Canada

Patients applied

0 patients applied

Trial Officials

Anita W Asgar, MD

Principal Investigator

Montreal Heart Institute

Anique Ducharme, MD

Principal Investigator

Montreal Heart Institute

Jean L Rouleau, MD

Study Chair

Montreal Heart Institute

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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